PAIN CONTROLS

Condition/Intervention

  • Peripheral neuropathy

Study Name

Patient Assisted Intervention for Neuropathy: Comparison of Real Life Situations (PAIN CONTROLS)

Summary  

The purpose of this study is to examine the safety and effectiveness of the drugs nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory polyneuropathy (CSPN). Peripheral neuropathy may cause weakness, numbness, tingling and pain in the hands, feet and other areas of the body. In approximately 25 to 50 percent of individuals with peripheral neuropathy, the cause is unknown. These cases may be diagnosed as CSPN.

Nortriptyline, duloxetine, pregabalin and mexiletine are approved by the U.S. Food and Drug Administration (FDA) to treat other conditions, but they are not approved for the treatment of CSPN. Participants will be assigned to receive one of these medications.

Inclusion Criteria

  • Age 30 or older
  • Diagnosis of cryptogenic sensory polyneuropathy
  • Likert Pain Score of greater than or equal to 4
  • Not currently taking nortriptyline, duloxetine, pregabalin, mexiletine or similar class of medication for at least seven days before baseline study visit

Exclusion Criteria

  • Any medical condition or current medication that would prevent patients from taking nortriptyline, duloxetine, pregabalin or mexiletine
  • Unable to give consent
  • Unable or not willing to comply with the study parameters
  • Previously identified other causes of polyneuropathy

Principal Investigator

Richard Lewis, MD

Co-Investigator

Robert Baloh, MD, PhD

Study Coordinator and Contact

Katherine Fetterman (Ashley)
Phone: 310-423-8497
Email: katherine.fetterman@cshs.org

Status

Active

IRB No.

38551

More Information

Date Last Updated

09/15